New ISO 7000:2012 Edition on Graphical symbols for use on equipment — Registered symbols

ISO 7000 4th Edition, “Graphical symbols for use on equipment — Registered symbols,” has just been released.  The standard is providing information on an entirely new way of distributing the collection of graphical symbols for use on equipment or parts of equipment in order to instruct the user on its operation.  It is available now from Document Center Inc.

The new system provides no charge access to the entire database of symbols.  You will find not only the symbols from ISO 7000:2012, but also the reference number and title for each.  However, the symbols themselves are not available for free download.  Instead, each will be purchased separately.

Each symbol has a small fee attached to its purchase, but there is a significant handling charge for each order.  Document Center suggests that you bundle together your purchase, aggregating as many symbols as you need into one order.

The URL for the new online browsing platform, which is in beta at this time, is cdb.iso.org.  At first, it’s probably easiest to run a query to find all the symbols.  Just type ISO in the search field (leave default filter where it is on All).  At the next screen, click the word “Symbols” on the left sidebar.  You should now see a page of symbols with a number attached to each.  Click on the symbol itself and you’ll get the complete bibliographic information for it.

You will soon learn to use the database to find symbols by the applicable ISO standard, code or topic (term).  However, it does take some playing around to get proficient using this new tool.

Once you know what symbols you need, feel free to order them from Document Center Inc.  You can order using a PO# on a net 30 basis or with your credit card, provided you’re in the United States.  Otherwise, prepayment is required.  Should you have any questions, please contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to assist you with this new product.

Proposed changes to OMB Circular A-119 could impact the Standards Community

On February 27th of this year, a Federal Register notice called for comment on a petition filed by a group of academics.  This petition would amend the OMB Circular A-119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.”

The Circular has been instrumental in directing Federal regulators, including the Department of Defense specifications and standards program, to move from government developed and maintained standards to the adoption of industry standards.  It has had a huge impact on the entire process of developing and implementing standards for both industry and government.

The usual process for government adoption of standards for regulatory processes is for industry standard in question to be called out by number, including date, in the applicable volume of the Code of Federal Regulations (CFR’s).  There are over 9,000 such references in federal regulations at this time.

In the main, these industry documents must be purchased by those needing to comply with the law.  This allows the  standards organization that develop, monitor, and revise the standards to fund the costs associated with this caretaking activity.

Indeed, the original impetus for the Circular in the first place was to reduce government expense by avoiding duplicate activity within both the private and public sector.  It was intended to pave the way for more government participation in industry standards-making processes, including the costs involved in such participation.  However, it must be remembered that those costs are not only borne by those who develop the standards, but also by those who use them through the vehicle of the purchase price.  Further, industry standards are normally copyright material, with the full protection afforded by that coverage.

The petition by the academics seeks to make standards that are referenced in the CFR’s available on the Internet at no charge.  “Today, binding law cannot be regarded as ‘reasonably available’  if it cannot freely be found in or through an agency’s electronic library.”  The petition goes on to suggest that perhaps this could be provided through a licensing agreement between the agencies involved and the standards associations themselves.

Of course, there is the further question of how such free, public availability of certain standards would impact revenue from sales that are not related to the use of the regulation itself.  My own use of search engines to find specific standards has lead me to find approximately a half-dozen illegal sites involved in the unauthorized sale of copyright material.  This suggests that  the public is still interested in inexpensive or free standards without regards to the economic impact of such transactions.

As one would expect, the standards community in the U.S. is very interested in the results such a change would have on the entire standards process.  ANSI is accepting a leadership role in voicing the concerns of Standards Developing Organizations (SDO’s) to the issues raised by the petition.

Document Center Inc. monitors such activity on a regular basis and is also concerned about how this petition would change the financial structure for SDO’s.  We’ll cover the ANSI response to the call for comments in a blog next week.  Meantime, if you have comments, please let us know.

Corrections issued in latest edition of BS EN ISO 25539-2, Cardiovascular implants – Endovascular devices – Vascular stents

BS EN ISO 25539-2:2009 has been corrected with the addition of a new 2012 Corrigendum.  The standard, “Cardiovascular implants. Endovascular devices. Vascular stents,” is modified by corrections to the National Forward.  Like all British Standards, it is available now from Document Center Inc.

This British Standard is the UK implementation of EN ISO 25539-2:2009, incorporating the corrigendum from February 2011. It is identical to ISO 25539-2:2008.  And it supersedes BS EN ISO 25539-2:2008, which is now obsolete.

Together with BS EN ISO 25539-1:2009, BS EN ISO 25539-2 supersedes BS EN 14299:2004, which is withdrawn.  And along with BS EN ISO 25539-1:2009 and BS EN ISO 25539-3:2011, it replaces BS EN 12006-3:1998+A1:2009, which is also withdrawn.

You’ll notice that the adopted ISO standard has not changed, even though the BS EN ISO 25539-2:2009 has been reissued twice with corrections.  This is because the corrections center on the administrative adoption and implementation process, not on the technical information in the standard itself.

Order this item by going to our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards and technical documentation requirements.

Editorial Changes issued for ASTM E1417, Standard Practice for Liquid Penetrant Testing

Recently ASTM International reissued the ASTM E1417-11 Edition, “Standard Practice for Liquid Penetrant Testing,” with editorial corrections.  Editorial corrections to an ASTM standard means that the technical content remains unchanged but that the text of the standard has been modified in some way.  The new ASTM E1417-11(e1) Edition is available from Document Center Inc. now.

For the ASTM E1417, the editorial changes included corrections to the metric conversions of subsection 6.6.2, deletion of some material in subsection 7.3.4.2, and addition of a phrase in subsection 7.8.2.6.

Since this standard is widely used in the industry, many of our customers are purchasing the corrected copy.  FYI: the document establishes the minimum requirements for conducting liquid penetrant examination of nonporous metal, and nonmetal components.

Established in 1898 originally as the American Society for Testing and Materials, ASTM International is one of the largest voluntary standards developing organizations in the world.  It provides a forum for the development and publication of international voluntary consensus standards for materials, products, systems and services.  The organization has developed over 12,000 technical documents that are a basis for manufacturing, management, procurement, codes and regulations.

All these current ASTM standards, plus many obsolete editions as well, are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been a licensed dealer of the ASTM standards since the 1980’s.

New ISO standards ISO 28802 and ISO 28803 address Ergonomics of the physical environment

For those of you interested in Human Factors, you may be aware that there is an ISO series concerned with the ergonomics of the physical environment.  Now two new ISO standards in the set are  available from Document Center Inc.

The first, ISO 28802, “Ergonomics of the physical environment — Assessment of environments by means of an environmental survey involving physical measurements of the environment and subjective responses of people,”  presents methods for the evaluation of comfort using physical measures of the environment and subjective measures from people.  The second, ISO 28803, “Ergonomics of the physical environment — Application of International Standards to people with special requirements,”  includes a description of the range and variety of responses and adaptations to physical environments of people with special requirements, and the consequences for measuring and evaluating those environments.

ISO 28802:2012 presents methods for the evaluation of comfort using physical measures of the environment and subjective measures from people. It provides methods for the assessment of thermal, acoustic, visual and lighting, and air quality environments, as well as other relevant environmental components.

For each environmental component, methods are provided for measuring the physical environment and subjective responses to the environment. An assessment form for use as an environmental assessment tool by the person conducting the survey is also included.

The new standard complements others in the series concerned with specific components of the environment, such as thermal environments, acoustics, lighting or air quality, building upon them to allow an assessment of human response to the total environment.

ISO 28803:2012, on the other hand, considers the application of indices and methods for people with special requirements where health and safety, comfort and well-being are considerations.  It provides a description of the nature of the particular characteristics of people with special requirements in the context of their responses to environments (e.g. restricted sensation, reduced perception or ability to respond).

It is not a database of characteristics of people with special requirements, but uses data from ISO/TR 22411 (Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities) to provide methods and criteria that will in turn provide accessible environments.

All ISO standards are available for purchase at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been selling standards for 30 years and can assist you with all your compliance requirements.

New ASTM E10 2012 Edition on Standard Test Method for Brinell Hardness of Metallic Materials

ASTM International has released the new ASTM E10-12, “Standard Test Method for Brinell Hardness of Metallic Materials,” and it’s available now from Document Center Inc.  The test is an indentation hardness test that can provide useful information about metallic materials.  ASTM E10 provides the requirements for a Brinell testing machine and the procedures for performing Brinell hardness tests.

This information may correlate to tensile strength, wear resistance, ductility, or other physical characteristics of metallic materials, and may be useful in quality control and selection of materials.

Brinell hardness tests are considered satisfactory for acceptance testing of commercial shipments, and have been used extensively in industry for this purpose.  However, brinell hardness testing at a specific location on a part may not represent the physical characteristics of the whole part or end product.

ASTM International develops thousands of test methods for a wide range of materials and processes.  All are available from Document Center Inc. in paper or pdf format at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  ASTM standards can be purchased in current or obsolete editions.  Just  ask our expert staff for assistance with the documents you need.

The new ASME B30.5 2011 Edition, Mobile and Locomotive Cranes, has just been released

ASME B30.5-2011 Edition, “Mobile and Locomotive Cranes,” has just been released and is available from Document Center Inc. now.  The standard addresses crawler cranes, locomotive cranes, wheel-mounted cranes, and any fundamentally similar cranes that are powered by internal combustion engines or electric motors.  It is intended for use by manufacturers, owners, employers, users and others concerned with the specification, buying, maintenance, training and safe use of mobile and locomotive cranes with B30 equipment, plus all potential governing entities.

ASME B30.5 offers comprehensive solutions applying to the construction, inspection, testing, maintenance and operation of mobile and locomotive cranes.  It is to be used in conjunction with equipment described in other volumes of the ASME B30 series of safety standards.

This 64-page edition incorporates revisions to requirements for operating near electrical power lines, defines critical lift, and offers a non-mandatory guidance document on identification and planning for critical lifts.  Additional updates have been made throughout to reflect current industry best-practices.

Side boom tractors and cranes designed for railway and automobile wreck clearance, digger derricks, cranes manufactured for or used for energized electrical line service, knuckle boom, trolley boom cranes, and cranes having a maximum rated capacity of one ton or less are excluded from ASME B30.5.

Document Center Inc. sells all ASME standards on our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been providing our customers with standards and compliance information for 30 years and would be happy to assist you too!

There’s a new ISO 11137-2 2012 Edition, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

The International Organization for Standardization (ISO) has just released the new 2nd Edition for ISO 11137-2, “Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.”   Widely adopted, the standard specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility.  It is available from Document Center Inc. now.

The standard provides methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6.  It also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

In addition, ISO 11137-2:2012 defines product families for sterilization dose establishment and sterilization dose audit.  It is one of a 3-part series on the sterilization of health care products using radiation that replaced the original edition, ISO 11137:1995.  The other two documents in the series are:

  • ISO 11137-1:2006, “Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
  • ISO 11137-3:2006, “Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects”

There is a draft amendment in process for the ISO 11137-1 so we may see additional activity on that item as well.

Because the document is so widely adopted by other standards jurisdictions (the European Union, the U.S. and so on), we expect to see the usual trickle down effect, with new editions of the adoptions being issued soon.

All ISO standards are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to assist you with all your Standards and Compliance requirements.

New MEDDEV 2.12-1 Revision 7 on Guidelines on a Medical Devices Vigilance System

The new MEDDEV 2.12/1 Revision 7 has just been released.  Titled “Guidelines on a Medical Devices Vigilance System,” the new document is available from Document Center Inc.  now.  The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients.  This is to be achieved by evaluating reported incidents and, where appropriate, disseminating information which could be used to prevent any repetitions, or to alleviate the consequences of such events.

The guideline is intended to facilitate the uniform application and implementation of the Medical Device Vigilance System requirements contained in three European Directives:

  • the Directive for Active Implantable Medical Devices (AIMD), 90/385/EEC
  • the Directive for Medical Devices (MDD), 93/42/EEC
  • and the In Vitro Diagnostic Medical Devices Directive (IVDD), 98/79/EC.

Revision 7 of MEDDEV 2.12-1 incorporates two new Report Forms (Annex 6-Manufacturer’s Periodic Summary Report and Annex 7- Manufacturer’s Trend Report Form) and updates two existing Report Forms (Annex 3 and Annex 4).  Field Safety Corrective Action (FSCA), Field Safety Notice (FSN), Use Error and Abnormal Use are new concepts introduced in this revision of the guideline.   The revised guidance will be applicable as of June 15th, 2012.

Corrective action includes   a device recall, the issue of a Field Safety Notice, additional surveillance/modification of devices in use, modification of future device design and/or components and/or the manufacturing process, and modification to labeling and/or instructions for use.

The MEDDEV guidelines in general are a set of documents relating to questions of application of EC-Directives on medical devices. They are not legally binding. The guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, and so on).

They are available from Document Center Inc. at our website, www.document-center.com.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Because we have a large number of medical device manufacturers as customers, we particularly catalog and monitor a number of medical device documents that cannot be found at other standards vendors.

New ISO/TS 14033 2012 Edition, Environmental management – Quantitative environmental information – Guidelines and examples

ISO 14033 1st Edition, “Environmental management – Quantitative environmental information – Guidelines and examples,” has just been released and is available from Document Center Inc.  Part of the ISO 14000 series on environmental management, the 43-page standard supports the application of standards and reports on environmental management.  As such, the new document supplements the contents of other International Standards in the series.

ISO/TS 14033:2012 addresses issues related to defining, collecting, processing, interpreting and presenting quantitative environmental information. It provides guidelines on how to establish accuracy, verifiability and reliability for the intended use. It utilizes proven and well-established approaches for the preparation of information adapted to the specific needs of environmental management.

You’ll find information on how to acquire quantitative environmental information and data and implement methodology.  The standard also covers the general principles, policy, strategy and activities necessary to obtain quantitative environmental information for internal and/or external purposes.

This Technical Specification could be used, for example, to support the establishment of inventory routines and make decisions related to environmental policies and strategies which are aimed at comparing quantitative environmental information.

The information is related to organizations, activities, facilities, technologies or products.  It is applicable to all organizations, regardless of their size, type, location, structure, activities, products, level of development and whether or not they have an environmental management system in place.

All ISO Standards are available from Document Center Inc.’s website, www.document-center.com.  If you’d like more information on the other Environmental Management Standards, please contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our expert staff will be happy to assist you.